Evidence map›Paper›PMID 33958748›Full record

ArticleGenetics in medicine : official journal of the American College of Medical Genetics2021

Laboratory business models and practices: implications for availability and access to germline genetic testing.

Maren T Scheuner, Michael P Douglas, Paloma Sales, Sara L Ackerman, Kathryn A Phillips

Abstract read
In one paragraph

Article in Genetics in medicine : official journal of the American College of Medical Genetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Financial assistance programs for genetic testing: Effective, ethical, and sustainable pathways to improving access disparities?Genetics in medicine : official journal of the American College of Medical Genetics · 2025
    Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Maren T ScheunerCenter for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California-San Francisco, San Francisco, CA, USA. maren.scheuner@va.gov.ORCID 0000-0002-9105-1369
Michael P DouglasCenter for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California-San Francisco, San Francisco, CA, USA.
Paloma SalesSan Francisco VA Health Care System, San Francisco, CA, USA.
Sara L AckermanDepartment of Social and Behavioral Sciences, University of California-San Francisco, San Francisco, CA, USA.
Kathryn A PhillipsCenter for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California-San Francisco, San Francisco, CA, USA.

Funding

Sharing Aggregate Genomics Research Findings with Diverse Participants: A Pilot Study of an Innovative Design StrategyU01HG009599 · NHGRI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KOENIG, BARBARA A., KWOK, PUI-YAN · 2017 to 2021
$16.3M
Coverage, Price, and Reimbursement for Multigene Tests for Cancer and Related ConditionsR01CA221870 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI PHILLIPS, KATHRYN A · 2018 to 2020
$2.2M
NCI NIH HHS R01 CA221870NHGRI NIH HHS U01 HG009599
6 · The paper itself

Abstract

purposeGermline testing laboratories have evolved over several decades. We describe laboratory business models and practices and explore their implications on germline testing availability and access.

methodsWe conducted semistructured interviews with key informants using purposive sampling. We interviewed 13 key informants representing 14 laboratories. We used triangulation and iterative data analysis to identify topics concerning laboratory business models and practices.

resultsWe characterized laboratories as full-service (FSL), for-profit germline (PGL), and not-for-profit germline (NGL). Relying on existing payer contracts is a key characteristic of the FSL business models. FSLs focus on high-volume germline tests with evidence of clinical utility that have reimbursable codes. In comparison, a key business model characteristic of PGLs is direct patient billing facilitated by commodity-based pricing made possible by investors and industry partnerships. Client billing is a key business model characteristic of NGLs. Because many NGLs exist within academic settings, they are challenged by their inability to optimize laboratory processes and billing practices.

conclusionContinued availability of, and access to germline testing will depend on the financial success of laboratories; organizational characteristics of laboratories and payers; cultural factors, particularly consumer interest and trust; and societal factors, such as regulation and laws surrounding pricing and reimbursement.

Indexed as

Genetic TestingLaboratoriesGerm CellsHumans

Identifiers

PMID33958748
PMCPMC8460432

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.